Recall Z-1805-2026 ยท LLZ System, Image Processing, Radiological
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
| Date | Apr 10, 2026 (initiated Mar 19, 2026) |
| Status | Open, Classified |
| Reason | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions. |
| Root cause | Labeling design |
| Action | Philips notified consignees on about 03/19/2026 via "URGENT Medical Device Correction" letter. Consignees were instructed NOT to use the MAFA ration for clinical decision making as indicated in the IFU and that AneurysmFlow may continue to be used in accordance with the Instructions for Use (IFU). Additionally, consignees were instructed to circulate the URGENT Medical Device Correction letter to all users so that they are aware of the issue and keep this URGENT Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure the letter is in a |
| Quantity | 1,033 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bnis insted Us Instas instes, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Greece, Indonesia, Iraq, Italy, Japan, Kuwait, Latvia, Ma |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160455 | AneurysmFlow Philips Medical Systems Nederland B.V., Aug 25, 2016 |